Class 2 Device Recall DRX Revolution Mobile Xray System

• Date Initiated by Firm: June 19, 2013
• Date Posted: November 01, 2013
• Recall Status: Terminated on May 20, 2016
• Recall Number: Z-0132-2014
• Recall Event ID: 65586
• 510(K)Number: K120062
• Product Classification: System, x-ray, mobile - Product Code IZL
• Product: DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas
• Code Information: Serial Numbers: All serial numbers manufactured since inception in June 21, 2012 until June 12, 2013
• Recalling Firm/ Manufacturer: Carestream Health Inc.; 150 Verona St; Rochester NY 14608-1733
• For Additional Information Contact: 800-328-2910
• Manufacturer Reason for Recall: Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column.
• FDA Determined Cause: Device Design
• Action: The firm, Carestream Health Inc., sent a "URGENT: Medical Device Recall" letter dated June 17, 2013 via courier service to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that there is no opportunity for interference between the End Cover and potential obstructions as the column is descending. Carestream will deploy a field service representative to apply a warning label to the column, and to provide an addendum to the Safety and Regulatory Information manual. Your Carestream service representative will contact you to answer any questions and schedule a visit as soon as possible. If you have any questions or concerns, please contact the Carestream Customer Care Center at 1-800-328-2910 from 8am through 8pm.
• Quantity in Commerce: 331 units
• Distribution: Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, IO, KS, LA, MA, MD, MI, MN, MO, NC, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV; and countries of: Australia, Brazil, Canada, Dubai, Germany, Japan, Kuwait, Malaysia, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, and Thailand.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IZL